TGA approves new severe asthma treatment Exdensur for Australians

A newly registered asthma treatment has been given the green light by the Therapeutic Goods of Australia (TGA), which could be a game changer for about 200,000 Australians living with severe asthma.

The new treatment – Exdensur – acts as extra maintenance for those aged over 12 living with the burden of severe asthma and chronic rhinosinusitis with nasal polyps.

The game-changing treatment is the first to be approved in Australia, and could offer a lifeline for Australians like Julia Ovens, who lives with severe asthma.

When Ms Ovens wakes up and gets ready for work, in many ways, she’s just like any other Melburnian, packing her bags and getting her lunch ready for her day at the office.

But unlike most, she also has to have a “battle plan” before she can even step outside, checking pollen levels and wind conditions.

Ms Ovens lives with severe eosinophilic asthma – a serious type of asthma that can lead to shortness of breath, chest tightness and chronic nasal problems – and even the smallest change can make life exceedingly difficult.

“Living with severe asthma means constantly thinking ahead. I avoid known triggers where possible, monitor how I’m feeling throughout the day and always have back-up plans,” she told NewsWire.

“It can feel like having a full-time job managing your health before you’ve even started your actual job.”

Ms Ovens is one of the 200,000 Australians living with severe asthma, which can lead to debilitating and sometimes life-threatening symptoms.

One in 10 Australians experience chronic rhinosinusitis, and between 25 to 30 per cent can develop nasal polyps, which are soft and jelly-like growths in the nose.

“While everyone’s experience is unique, many people living with severe asthma describe the same constant vigilance,” Ms Ovens said.

“It’s the uncertainty that’s so difficult. It’s wondering whether you’ll make it through the day without a flare-up.”

The symptoms can even be life-threatening, she told NewsWire.

“Severe asthma is not ‘just asthma’,” Ms Ovens said.

“It’s a serious, chronic disease that affects people differently and can be life-threatening.”

This week, the TGA gave the green light for the registration of a game-changing treatment for Australians living with severe asthma.

Administered every six months via injection, the treatment works by targeting interleukin-5,
a protein that causes the body to make white blood cells called eosinophils.

Exdensur lowers the number of eosinophils to reduce airway and sinus inflammation.

“For many, it can offer a fantastic opportunity to improve asthma control and outcomes in this very hard to treat group with very severe asthma,” respiratory physician Jo Douglass told NewsWire.

She explained the treatment “attacks” eosinophils and reduces the number of inflamed cells in the lungs.

“The most prominent thing they do is reduce flare-ups or exacerbations of asthma,” Professor Douglass said.

“They give people more stable asthma so they’re not so likely to get at times when their symptoms are out of control and they need to seek additional medication.”

Professor Douglass said not only did the medication help reduce symptoms of severe asthma, it could also improve lung function.

“Many people notice that it also improves their symptoms and can improve lung function,” she said.

Some will start seeing improvements in their symptoms over the span of a few months or weeks, but Professor Douglass said some may see improvements in the first 24 hours.

“It just depends on the individual, but usually they work fairly quickly,” she said.

While the treatment has been registered with the TGA, it’s just the first step before it can be added to the Pharmaceutical Benefits Scheme, allowing Australians to access the treatment from their local GP.

Currently, those living with severe asthma have to visit a specialist before they’re prescribed the medication.

“Overall, the drug seems very safe and that is recognised in the Therapeutic Goods Administration listing of the drug,” Professor Douglass said.

“They’ve reviewed the safety profile and believe that’s acceptable.”

Biopharma company GSK Australia welcomed the treatment’s TGA’s registration.

Country medical director Sebastian DiNatalie said the treatment may “improve the lives of people living with complex inflammatory conditions”.

“We are pleased that Exdensur has now been registered by the TGA for eligible patients in Australia,” he said.

“We are now focused on the next step and look forward to working with the Australian government to support equitable access for Australians who may benefit from this treatment.”

For people like Ms Ovens, whose entire life is dictated by the severity of her asthma, the medication could be the ultimate game changer – and ultimately a lifesaver.

“Any new treatment option that has the potential to improve the lives of people living with severe eosinophilic asthma is incredibly encouraging,” she said.

“Severe asthma is a complex disease, and no single treatment works for everyone.

“That’s why it’s so important to continue developing new treatment options. Every additional therapy creates more opportunities to personalise care.”

Ms Ovens urged others to be aware of the severity and dangers of living with severe asthma.

“Asthma is a life-threatening condition that requires constant management and affects every aspect of our lives,” she said.

“At the end of the day, what everyone living with severe asthma wants is not sympathy or special treatment, just the freedom to breathe, to live fully and to stop thinking about their next breath.”